After February 21, 2019, new FDA requirements for clinical investigations went into effect. These requirements are intended to ensure clinical data quality and integrity, as well as to protect human subjects’ well-being and safety. As a way of keeping domestic and international premarket medical device submissions consistent for regulatory review, the new acceptance criteria take aim at very particular issues in the compliance process for clinical investigations.

Learn how activities like Use Error Analysis can lead to more dynamic, impactful risk management.

While this was a slower month than usual due to the government shutdown, FDA has still been active. Here are a few important updates from January 2019 your life science organization may want to keep up with.

No doubt: 2018 was an important—and extremely busy—year for FDA. Between engaging with the 21st Century Cures Act and applying critical updates to long-standing programs, the agency has spent the past year working hard to position itself well in the changing landscape of life science industries. While there’s a lot worth discussing about the regulatory year that was 2018, a few important milestones are worth a second look.

The year has drawn to a close, but FDA is not slowing down its pace. December 2018 was a big month for the agency, and there’s a lot to talk about. Here are a few important updates to catch up on as we prepare to move into the new year.

For FDA, 2018 was a busy year; the agency began a number of new initiatives, released a plethora of new draft guidance, and took major steps toward greater collaboration among themselves, industry, and other agencies. In the coming year, expect these efforts to keep going and important new initiatives to take flight. In preparing for these regulatory actions, there are four main trends to watch out for.

Next year is shaping up to be big for FDA. Continued initiatives for digital health innovation, industry collaboration, and improving premarket submission processes are going to influence many regulatory actions in 2019. FDA has anticipated this by putting out a list of proposed guidance for development in 2019. The list lacks details on what any new guidance will look like, however. Exploring what’s been proposed, while not definitive, can give your medical device organization a better sense of what FDA might be up to in the coming year.